A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature
Eosinophilic esophagitis (EoE) is a chronic disease, characterized clinically by esophageal disfunction. Topical corticosteroids (tCS), predominantly fluticasone and budesonide, are considered the effective first line treatment, as well as an option of maintenance therapy in EoE. The way that tCS ar...
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| Format: | Article |
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MDPI AG
2022-11-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/22/6730 |
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| author | Joanna Warzecha Marcin Dziekiewicz Alicja Bieńkowska-Tokarczyk Maciej Małecki Aleksandra Banaszkiewicz |
| author_facet | Joanna Warzecha Marcin Dziekiewicz Alicja Bieńkowska-Tokarczyk Maciej Małecki Aleksandra Banaszkiewicz |
| author_sort | Joanna Warzecha |
| collection | DOAJ |
| description | Eosinophilic esophagitis (EoE) is a chronic disease, characterized clinically by esophageal disfunction. Topical corticosteroids (tCS), predominantly fluticasone and budesonide, are considered the effective first line treatment, as well as an option of maintenance therapy in EoE. The way that tCS are administered significantly affects their effectiveness. There is still no ready-to-use steroid drug to be applied topically to the esophagus in children—a few experimental viscous slurries (mainly of budesonide) have been shown in trials to be more effective than steroids administered via metered dose inhalers (MDIs) and swallowed. The best examined steroid solvent of all is sucralose, a high-intensity artificial sweetener. Although it has been shown in a critical review that it is non-toxic and safe for all consumers, there are still some concerns among patients about its potential adverse effect on humans. Due to that fact, we developed a new viscous formulation and evaluated its effectiveness in the treatment of children with EoE. In an open, prospective, single-center study, we administered our new formulation of viscous budesonide twice daily for 8 weeks in patients with an active EoE. After treatment, we performed a control gastroscopy with the collection and evaluation of histopathological samples. We have proven our formulation effectiveness at 64%, as far as histological remission is concerned. We have also shown a reduction in the mean endoscopic reference score (EREFS) from 3.1 points at the beginning of the study to 1.6 points at the end of the study. Bearing in mind how important the acceptance of the solvent is for long-time compliance, especially among children, we also decided to assess the taste of the formulation. Therefore, we asked 46 adults and 10 children to swallow a sample of the solvent and fill in a short anonymous questionnaire about its taste, smell, consistency and easiness of swallowing. General acceptance for the proprietary solvent was high, reaching 7.5/10 among adults and 6.5/10 in children. To be able to compare the results of our preliminary experience, we reviewed the studies which evaluated substances that have been used so far as steroid solvents for the treatment of EoE. The overall effectiveness of the oral viscous budesonide (OVB) ranged from 65% to 90%, which is consistent with the results obtained in our study. Unfortunately, the high heterogeneity of the studies did not allow us to draw reliable conclusions. |
| first_indexed | 2024-03-09T18:14:34Z |
| format | Article |
| id | doaj.art-46c04fec81d445319e216024037942cd |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T18:14:34Z |
| publishDate | 2022-11-01 |
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| series | Journal of Clinical Medicine |
| spelling | doaj.art-46c04fec81d445319e216024037942cd2023-11-24T08:49:11ZengMDPI AGJournal of Clinical Medicine2077-03832022-11-011122673010.3390/jcm11226730A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the LiteratureJoanna Warzecha0Marcin Dziekiewicz1Alicja Bieńkowska-Tokarczyk2Maciej Małecki3Aleksandra Banaszkiewicz4Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, 02-097 Warsaw, PolandDepartment of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, 02-097 Warsaw, PolandDepartment of Applied Pharmacy, Faculty of Pharmacy, Medical University of Warsaw, 02-097 Warsaw, PolandDepartment of Applied Pharmacy, Faculty of Pharmacy, Medical University of Warsaw, 02-097 Warsaw, PolandDepartment of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, 02-097 Warsaw, PolandEosinophilic esophagitis (EoE) is a chronic disease, characterized clinically by esophageal disfunction. Topical corticosteroids (tCS), predominantly fluticasone and budesonide, are considered the effective first line treatment, as well as an option of maintenance therapy in EoE. The way that tCS are administered significantly affects their effectiveness. There is still no ready-to-use steroid drug to be applied topically to the esophagus in children—a few experimental viscous slurries (mainly of budesonide) have been shown in trials to be more effective than steroids administered via metered dose inhalers (MDIs) and swallowed. The best examined steroid solvent of all is sucralose, a high-intensity artificial sweetener. Although it has been shown in a critical review that it is non-toxic and safe for all consumers, there are still some concerns among patients about its potential adverse effect on humans. Due to that fact, we developed a new viscous formulation and evaluated its effectiveness in the treatment of children with EoE. In an open, prospective, single-center study, we administered our new formulation of viscous budesonide twice daily for 8 weeks in patients with an active EoE. After treatment, we performed a control gastroscopy with the collection and evaluation of histopathological samples. We have proven our formulation effectiveness at 64%, as far as histological remission is concerned. We have also shown a reduction in the mean endoscopic reference score (EREFS) from 3.1 points at the beginning of the study to 1.6 points at the end of the study. Bearing in mind how important the acceptance of the solvent is for long-time compliance, especially among children, we also decided to assess the taste of the formulation. Therefore, we asked 46 adults and 10 children to swallow a sample of the solvent and fill in a short anonymous questionnaire about its taste, smell, consistency and easiness of swallowing. General acceptance for the proprietary solvent was high, reaching 7.5/10 among adults and 6.5/10 in children. To be able to compare the results of our preliminary experience, we reviewed the studies which evaluated substances that have been used so far as steroid solvents for the treatment of EoE. The overall effectiveness of the oral viscous budesonide (OVB) ranged from 65% to 90%, which is consistent with the results obtained in our study. Unfortunately, the high heterogeneity of the studies did not allow us to draw reliable conclusions.https://www.mdpi.com/2077-0383/11/22/6730eosinophilic esophagitisoral viscous budesonidetopical steroidsformulationtreatmentviscous slurry |
| spellingShingle | Joanna Warzecha Marcin Dziekiewicz Alicja Bieńkowska-Tokarczyk Maciej Małecki Aleksandra Banaszkiewicz A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature Journal of Clinical Medicine eosinophilic esophagitis oral viscous budesonide topical steroids formulation treatment viscous slurry |
| title | A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature |
| title_full | A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature |
| title_fullStr | A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature |
| title_full_unstemmed | A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature |
| title_short | A New Viscous Budesonide Formulation for the Treatment of Eosinophilic Esophagitis in Children: A Preliminary Experience and Review of the Literature |
| title_sort | new viscous budesonide formulation for the treatment of eosinophilic esophagitis in children a preliminary experience and review of the literature |
| topic | eosinophilic esophagitis oral viscous budesonide topical steroids formulation treatment viscous slurry |
| url | https://www.mdpi.com/2077-0383/11/22/6730 |
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